NCT00072007已完成2 期
2-CDA and Rituximab as Remission Induction and Rituximab as In Vivo Purging Prior to Peripheral Stem Cell Mobilization in Patients With Chronic Lymphocytic Leukemia (CLL) - A Prospective Multicenter Phase II Trial
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 22
- 主要终点
- Complete-remission rate after induction
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as cladribine, use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining cladribine with rituximab may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving cladribine and rituximab as remission induction therapy together with rituximab and stem cell mobilization in treating patients with chronic lymphocytic leukemia.
详细描述
OBJECTIVES:
Primary
- Determine the efficacy and tolerability of cladribine and rituximab as remission induction therapy in patients with chronic lymphocytic leukemia.
- Determine the complete remission rate in patients treated with this regimen.
Secondary
- Determine the very good partial remission rate and nodular partial remission rate in patients treated with this regimen.
- Determine the toxicity of this regimen, in terms of hemotoxicity and infection rate, in these patients.
- Determine the efficacy of in vivo purging with rituximab measured by immunophenotyping in these patients.
- Determine the feasibility of stem cell harvest in these patients after treatment with this induction therapy regimen and in vivo purging with rituximab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of B-cell chronic lymphocytic leukemia (CLL)
- •CD5 positive and CD23 positive
- •Binet stage B, C, or progressive A
- •Newly diagnosed disease OR no more than 1 prior alkylating agent regimen (e.g., chlorambucil or cyclophosphamide with or without prednisone)
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •No autoimmune hemolytic anemia
- •No immune thrombocytopenia
- •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •Alkaline phosphatase no greater than 2.5 times ULN*
- •AST and ALT no greater than 2.5 times ULN* NOTE: *Unless clearly related to CLL liver involvement
- •Creatinine clearance greater than 50 mL/min
- •Cardiovascular
- •Ejection fraction at least 50%
- •No severe heart failure
- •No unstable angina pectoris
- •No significant arrhythmia requiring chronic treatment
- •No myocardial infarction within the past 3 months
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 12 months after study participation
- •HIV negative
- •No active infection
- •No positive Coombs' test
- •No history of significant neurologic or psychiatric disorders, including psychotic disorders or dementia
- •No seizure disorder
- •No other malignancy within the past 5 years except nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix
- •No prior allergic reaction or hypersensitivity to study drugs or attributed to compounds of similar chemical or biological composition to study drugs or other study agents
- •No uncontrolled diabetes mellitus
- •No gastric ulcers
- •No active autoimmune disease
- •No alcohol or drug abuse
- •No other concurrent serious underlying medical condition that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •See Disease Characteristics
- •No prior purine analogs (e.g., cladribine or fludarabine)
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •No concurrent radiotherapy
- •Not specified
- •More than 30 days since prior clinical trial participation
- •No other concurrent experimental drugs
排除标准
- 未提供
结局指标
主要结局
Complete-remission rate after induction
时间窗: 30 days
次要结局
- Very good partial remission and nodular partial remission after induction(30 days)
- Toxicity (hematotoxicity and infection rate) at 30 days following study treatment(30 days)
研究者
研究点 (22)
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